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12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE4

12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder

A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder

NCT01316302•The Medical Research Network

View on ClinicalTrials.gov

Summary

This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).

Detailed Description

Social Anxiety Disorder (SAD) is recognized as a prevalent, chronic and disabling condition. Lifetime prevalence has been estimated at 13% in the National Comorbidity Survey. There is good reason to think that Pristiq® would be effective in Social Anxiety Disorder. Effexor XR, which is mechanistically similar to Pristiq®, was found effective for subjects with Generalized Social Anxiety Disorder in all five of the placebo controlled trials in which it was studied.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must give written informed consent prior to any study procedures.
•Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder, Generalized Subtype) according to DSM-IV-TR criteria, as determined by psychiatric evaluation with the Principal Investigator.
•A minimum score of 60 on the LSAS total score at both Screening and Baseline visits.
•A total HAM-D score of less than 15 at the Screening visit.
•CGI Severity score of 4 or greater at both Screening and Baseline visits.
•Female subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial. Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), and implantable contraceptive devices.

Exclusion Criteria

•An Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit. Subjects with co-morbid MDD, GAD, dysthymia, or specific phobias will be allowed if GSAD is the primary disorder in terms of clinical severity, as determined by the investigator.
•Any history or complication of schizophrenia or bipolar disorder.
•Any complication of body dysmorphic disorder.
•Substance dependence, as defined by DSM-IV-TR criteria, within 24 weeks of the Baseline visit.
•Subjects who are currently pregnant, lactating, or of childbearing potential and not practicing an effective method of contraception.
•Subjects scoring \>2 on item #3 of the HAM-D, or who, in the opinion of the PI, are at a clinically significant risk for suicide.
•Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95.
•Positive Urine Drug Screen at the Screening visit.
•Any current unstable and/or clinically significant medical condition, based on history or as evidenced in Screening laboratory and ECG assessments.
•Any history or complication of cancer or malignant tumor.
+5 more criteria

Locations (1)

The Medical Research Network, LLC

New York, New York, United States

Key Dates

Start Date

April 1, 2011

Primary Completion Date

November 1, 2012

Completion Date

December 1, 2012

Last Updated

October 17, 2016

Enrollment

ACTUAL participants

Conditions

Social Anxiety Disorder

Interventions

Pristiq

DRUG

Placebo

DRUG

ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence

NCT07456631

Social Anxiety Disorder (SAD)Oppositional Defiant Disorder

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RECRUITINGNA

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

NCT06661460

ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)Specific Phobia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder

Inclusion Criteria

Exclusion Criteria

ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

Individual Factors of CBT Underlying Success

Comparing TBT to Disorder-Specific Psychotherapy in Veterans With Social Anxiety Disorder

Application of Virtual Reality Technology to Treatment of Social Anxiety

Intervention Social Anxiety: Combining Parent-child Treatment